Cleared Special

LIAISON? VCA IgG and LIAISON? VCA IgG Serum Control Set; LIAISON? EBNA IgG and LIAISON? EBNA IgG Serum Control Set

K162961 · DiaSorin, Inc. · Microbiology
Jan 2017
Decision
73d
Days
Class 1
Risk

About This 510(k) Submission

K162961 is an FDA 510(k) clearance for the LIAISON? VCA IgG and LIAISON? VCA IgG Serum Control Set; LIAISON? EBNA IgG and LIAISON? EBNA IgG Serum Control Set, a Epstein-barr Virus, Other (Class I — General Controls, product code LSE), submitted by DiaSorin, Inc. (Stillwater,, US). The FDA issued a Cleared decision on January 5, 2017, 73 days after receiving the submission on October 24, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K162961 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2016
Decision Date January 05, 2017
Days to Decision 73 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LSE — Epstein-barr Virus, Other
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3235

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